Wearable physiologic sensing apparatus

ABSTRACT

The disclosure includes a system for sensing physiologic data. The system can include a flexible configured to wrap around a finger of a user, a first electrode coupled to the flexible strap, and a second electrode coupled to the flexible strap. The system can also include a sensor housing comprising at least one sensor configured to detect physiologic data from the finger and a data receiving module communicatively coupled to the first electrode, the second electrode, and the at least one sensor. The data receiving module can be configured to receive physiologic data from the at least one sensor.

STATEMENT REGARDING GOVERNMENT SPONSORED RESEARCH

This invention was made with government support under TR000346 awardedby the National Institutes of Health. The government has certain rightsin the invention.

CROSS-REFERENCE TO RELATED APPLICATIONS

The entire contents of the following application are incorporated byreference herein: U.S. Non-provisional patent application Ser. No.15/276,169; filed Sep. 26, 2016; and entitled WEARABLE PHYSIOLOGICSENSING APPARATUS.

The entire contents of the following application are incorporated byreference herein: U.S. Provisional Patent Application No. 62/234,015;filed Sep. 28, 2015; and entitled WEARABLE PHYSIOLOGIC SENSINGAPPARATUS.

BACKGROUND Field

The present disclosure relates to a wearable sensor for monitoringphysiologic signals for the treatment of medical and mental healthdisorders.

Description of Related Art

Typical devices for the measurement of physiologic parameters from thefingers require the placement of sensors on separate fingers, resultingin the transmission of physiologic signals from distinct fingers.Existing platforms for the sensing of physiologic signals may orient atemperature sensor on a pad of one finger, a pulse sensor, or possibly apulse oximeter on a pad of a second finger, and additional impedance orconductance sensors on pads of third and fourth fingers. This can resultin the reduced use of the hand dedicated to obtaining the physiologicmeasurements, and limits the scope of the devices to clinical settings,or minimally for applications where a user will not require the use ofthe hand dedicated to obtaining the physiologic signals. This may removethe user from situations and environments where the full use of one orboth hands are required.

Furthermore, the application of multiple sensors to multiple fingers istime consuming, increases the chance for errors to be made (e.g. sensornot connected or positioned incorrectly), and can reduce user compliancewith monitoring. Accordingly, there is a need for systems and methods toremedy the deficiencies as described above.

SUMMARY

In some embodiments, a system for sensing physiologic data comprises aflexible strap elongate along a first direction, the flexible strapconfigured to wrap around a finger of a user; a first electrode coupledto the flexible strap, the first electrode comprising a first electricalconductor configured to conductively couple to the finger; a secondelectrode coupled to the flexible strap and spaced from the firstelectrode along the first direction, the second electrode comprising asecond electrical conductor configured to conductively couple to thefinger; a sensor housing comprising at least one sensor configured todetect physiologic data from the finger; and a data receiving modulecommunicatively coupled to the first electrode, the second electrode,and the at least one sensor. The data receiving module can be configuredto receive physiologic data from the at least one sensor.

The at least one sensor can comprise at least one of a thermistor, aphoto detector, a pulse sensor, a photoplethysmography sensor, and aheat-flux sensor. As well, the first electrode and the second electrodecan define an electrodermal activity sensor.

In some embodiments, the finger defines a palmar surface that faces thesame direction as a palm of a hand of the user. When the system iscoupled to the finger of the user, the first and second electrodes maynot cover a central axis of the palmar surface of the finger.

Additionally, in some embodiments, when the system is coupled to thefinger of the user at least 50% of an area of the first and secondelectrodes contacts a lateral skin surface of the finger. In someembodiments, when the system is coupled to the finger of the user atleast 75% of the area of the first and second electrodes contacts thelateral skin surface of the finger.

The flexible strap may be stretchable with a modulus of elasticitybetween 0.05 and 1 lb/in of strap width. The flexible strap material mayalso be breathable, and have a moisture vapor transmission rate of atleast 300 grams/m²/24 hrs.

In some embodiments, the system comprises a cable that communicativelycouples the data receiving module with the first electrode, the secondelectrode, and the at least one sensor. The data receiving module maycomprise at least one of a smartphone, tablet, and smart watch.Additionally, the data receiving module may comprise a network interfaceconnected for wirelessly communicating data to another device.

Even still, in some embodiments, the system may comprise a first femalesnap coupled to the flexible strap and conductively coupled to the firstelectrode. The system may also comprise a second female snap coupled tothe flexible strap and conductively coupled to the second electrode.

In some embodiments, the first female snap is coupled to the firstelectrode via a first conductive portion that extends from a first sideportion of the flexible strap away from the first electrode along atleast the second direction that is perpendicular to the first direction.The first conductive portion can additionally extend away from the firstelectrode along the first direction. As well, in some embodiments, thesecond female snap is coupled to the second electrode via a secondconductive portion that extends from a second side portion of theflexible strap away from the second electrode along at least the seconddirection. The second conductive portion can additionally extend awayfrom the second electrode along the second direction.

Some embodiments of the system may further comprise a first male snapcoupled to the sensor housing, wherein the first male snap is arrangedand configured to snapably couple to the first female snap. Systems mayalso comprise a second male snap coupled to the sensor housing, whereinthe second male snap is arranged and configured to snapably couple tothe second female snap.

When the sensor housing is coupled to the flexible strap the firstfemale snap may fold toward a middle portion of the flexible strap tothereby snapably receive the first male snap and the second female snapmay fold toward the middle portion of the flexible strap to therebysnapably receive the second male snap. Additionally, when the sensorhousing is coupled to the flexible strap the sensor housing may extendalong a third direction that is perpendicular to the first direction andthe second direction.

In some embodiments, the sensor housing comprises a thermistor, a photodetector, and a light emitting diode all disposed along a first surfaceof the sensor housing, and the first male snap and the second male snapare disposed along a second surface of the sensor housing that facesopposite the first surface. As well, in some embodiments, when theflexible strap is wrapped around the finger of the user and the sensorhousing is coupled to the flexible strap, the thermistor, photodetector, and light emitting diode all face a skin surface of thefinger.

Some embodiments of the system may comprise a third electrode coupled tothe flexible strap and communicatively coupled to the data receivingmodule. The third electrode may be spaced from the first electrode alongeither the first direction or the second direction. As well, the thirdelectrode may comprise a third electrical conductor configured toconductively couple to the finger. The system may even comprise a fourthelectrode coupled to the flexible strap and communicatively coupled tothe data receiving module. The fourth electrode may be spaced from thethird electrode along the first direction. Additionally, the fourthelectrode may be spaced from the second electrode along either the firstdirection or the second direction. The fourth electrode may comprise afourth electrical conductor configured to conductively couple to thefinger.

The disclosure also includes a system for sensing physiologic data thatcomprises a flexible strap elongate along a first direction, theflexible strap configured to wrap around a finger of a user; a firstelectrode coupled to the flexible strap, the first electrode comprisinga first electrical conductor configured to conductively couple to thefinger; a second electrode coupled to the flexible strap and spaced fromthe first electrode along either the first direction or a seconddirection that is perpendicular to the first direction, the secondelectrode comprising a second electrical conductor configured toconductively couple to the finger; a third electrode coupled to theflexible strap and spaced from the first and second electrodes along thefirst direction, the third electrode comprising a third electricalconductor configured to conductively couple to the finger; a fourthelectrode coupled to the flexible strap, spaced from the first andsecond electrodes along the first direction, and spaced from the thirdelectrode along either the first direction or the second direction, thefourth electrode comprising a fourth electrical conductor configured toconductively couple to the finger; a sensor housing comprising at leastone sensor configured to detect physiologic data from the finger; and adata receiving module communicatively coupled to the first electrode,the second electrode, the third electrode, the fourth electrode, and theat least one sensor. The data receiving module may be configured toreceive physiologic data from the at least one sensor.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages are described belowwith reference to the drawings, which are intended to illustrate, butnot to limit, the invention. In the drawings, like reference charactersdenote corresponding features consistently throughout similarembodiments. The above and other features of the present invention willbecome more apparent by describing in detail exemplary embodimentsthereof with reference to the accompanying drawings, in which:

FIG. 1 illustrates a top view, or view that directly contacts the palmersurface of the finger, of the flexible strap, electrodes, and sensorhousing, according to some embodiments.

FIG. 2 illustrates a top view of the flexible strap and electrodes withhydrogel and protective liner and a top view of the sensor housing,according to some embodiments.

FIG. 3 illustrates a bottom view of the flexible strap and sensorhousing, according to some embodiments.

FIG. 4 illustrates the top view of the flexible strap, electrodes, andsensor housing, where the sensor housing is coupled to the flexiblestrap, according to some embodiments.

FIG. 5 illustrates the top view of the system, where the sensor iscoupled to the flexible strap, according to some embodiments.

FIG. 6 is a perspective view of system and illustrates how the systemcan be configured to wrap around the finger of the user to collect andtransmit physiological data of the user, according to some embodiments.

FIG. 7 illustrates a side view of the flexible strap, electrodes, andsensor housing, according to some embodiments.

FIG. 8 illustrates a side view of the system configured to wrap aroundthe finger of the user, according to some embodiments.

FIG. 9 illustrates a top view, or view that directly contacts the palmersurface of the finger, of the flexible strap, electrodes, and sensorhousing, according to various embodiments.

FIG. 10 illustrates typical EDA waveforms during cognitive and emotionalstressors, according to some embodiments.

FIG. 11 illustrates distributions of correlation coefficients for thelinear regressions of the BIOPAC and EDL measurements, according to someembodiments.

DETAILED DESCRIPTION

Although certain embodiments and examples are disclosed below, inventivesubject matter extends beyond the specifically disclosed embodiments toother alternative embodiments and/or uses, and to modifications andequivalents thereof. Thus, the scope of the claims appended hereto isnot limited by any of the particular embodiments described below. Forexample, in any method or process disclosed herein, the acts oroperations of the method or process may be performed in any suitablesequence and are not necessarily limited to any particular disclosedsequence. Various operations may be described as multiple discreteoperations in turn, in a manner that may be helpful in understandingcertain embodiments; however, the order of description should not beconstrued to imply that these operations are order dependent.Additionally, the structures, systems, and/or devices described hereinmay be embodied as integrated components or as separate components.

For purposes of comparing various embodiments, certain aspects andadvantages of these embodiments are described. Not necessarily all suchaspects or advantages are achieved by any particular embodiment. Thus,for example, various embodiments may be carried out in a manner thatachieves or optimizes one advantage or group of advantages as taughtherein without necessarily achieving other aspects or advantages as mayalso be taught or suggested herein.

Introduction

The physiologic signal-detecting system 10 can consist of at least 2electrodes and at least one additional physiologic sensor located on acommon finger 14. The system 10 can comprise a flexible strap 12, afirst electrode 16, a second electrode 20, a sensor 26, a sensor housing24, and a data receiving module 88. FIG. 6 illustrates a perspectiveview of a system 10 for sensing the physiological data 11 of a user 78.In some embodiments, the system 10 can comprise a flexible strap 12elongate along a first direction X. The flexible strap 12 can beconfigured to wrap around a finger 14 of a user 78.

Referring to FIG. 4, the system 10 can also comprise a first electrode16 that can be coupled to the flexible strap 12. The first electrode 16can comprise a first electrical conductor 18 that can be configured toconductively couple to the finger 14 (shown in FIG. 6). The system 10can include a second electrode 20 that can be coupled to the flexiblestrap 12 and can be spaced from the first electrode 16 along the firstdirection X. The second electrode 20 can comprise a second electricalconductor 22 that can be configured to conductively couple to the finger14. The system 10 can also include a sensor housing 24. The sensorhousing 24 can comprise at least one sensor 26 that can be configured todetect physiologic data 11 from the finger 14 (shown in FIG. 6).Additionally, the system can include a data receiving module 88 (shownin FIGS. 6 and 8) that can be communicatively coupled to the firstelectrode, second electrode, and at least one sensor 26. The datareceiving module 88 can be configured to receive physiologic data 11from at least one sensor 26.

As illustrated in FIGS. 6 and 8, in several embodiments of the system10, the finger 14 can define a palmar surface 76 that faces the samedirection as a palm 80 of a hand 84 of the user 78. In some embodimentsthe first electrode 16 and second electrode 20 (shown in FIGS. 1 and 4)may not necessarily cover a central axis of the palmar surface 76 of thefinger 14. The first electrode 16 and second electrode 20 may notnecessarily pass through the central axis of the palmar surface 76 ofthe finger 14. Instead, the first electrode 16 and second electrode 20may be positioned on the lateral surfaces 86 of the finger 14 and mayextend circumferentially around the finger 14. The first electrode 16and second electrode 20 may begin at, or near, (e.g. within 5 mm of) atleast one additional physiologic sensor located on the palmar surface 76of the finger 14 (e.g. on the finger pad). The lateral surfaces 86 canbe the sides of the finger 14 that are exposed when the finger 14 isclamped between two flat surfaces. In other words, the lateral sides canbe substantially perpendicular to the palmar surface 76 of the finger14, where the fingerprint is located.

In some embodiments, wherein the system 10 can be coupled to the finger14 of the user 78, at least 50% of the area of the first electrode 16and second electrodes 20 can contact a lateral surface 86 of the finger14. Additionally, in several embodiments, wherein the system 10 can becoupled to the finger 14 of the user 78, at least 75% of the area of thefirst electrode 16 and second electrode 20 can contact a lateral surface86 of the finger 14.

Furthermore, the sensor 26 may be located on a common finger 14 segment.Referring to FIG. 1, in several embodiments of the system 10, at leastone sensor 26 can comprise at least one of a thermistor 34, a photodetector 36, a pulse sensor 32, a photoplethysmography sensor 38, and aheat-flux sensor 40. Additional physiologic and movementcharacterization sensors may also be included with the sensor housing.

Electrodermal activity (EDA) refers to the conductance (or resistance,impedance, admittance) measurement made between electrodes positioned onthe skin of the patient when a direct or alternating current is drivenacross the electrodes. The measurement is typically made on the fingersand/or hand, but can also be made on the dermal surface of the trunk andextremities (e.g. feet, wrists). Typically two electrodes are used,although multiple electrodes can be used as described in US patentapplication US20150031964. Most of the measured conductance is due tothe electrode-skin contact resistance and the resistance of thesuperficial skin layer (e.g. stratum corneum). As a result, increases insweat in the sweat ducts and on the skin surface cause correspondingincreases in the conductance of the skin. This is known as EDA.

The term EDA is used herein to include both a tonic component (level)and a phasic component (response). The tonic component includeselectrodermal level (EDL), skin conductance level (SCL), skin impedancelevel, skin admittance level, etc. A phasic component or responseincludes skin conductance response (SCR), galvanic skin reflex, galvanicskin response (GSR), electrodermal response (EDR), skin impedanceresponse, skin admittance response, psychogalvanic reflex (PGR), etc. Inthe case of an AC measurement, it also includes a capacitive portion(susceptance) and phase angle. Referring the FIG. 1, the electrodermalactivity (EDA) sensor 42 can consist of a minimum of two electrodeslocated on each side of the pulse sensor 32.

Referring back to FIG. 1, the first electrode 16 and the secondelectrode 20 can comprise a first electrical conductor 18 and a secondelectrical conductor 22, respectively. The electrodes can be flexible,allowing the electrode surfaces to conform to the skin surface 202 of afinger 14. These conductors can be a thin metal film or tape, a polymeror adhesive impregnated with conductive material, or a coated fabric orfilm (e.g. conductive silver chloride ink printed on a polyester film).The first electrical conductor 18 and the second electrical conductor 22can comprise at least one of silver, silver chloride, carbon, copper,gold, stainless steel, nickel, platinum, or any other electricallyconductive material. The first electrode 16 and second electrode 20 maybe coated with a hydrogel 48 to improve conductivity and interfaceconsistency. The hydrogel 48 can help absorb excessive moisture andsupply moisture as the finger 14 dries. Hydrogel can also fill smallgaps between the finger 14 and first electrode 16 or second electrode20, which may not perfectly conform to the surface of the finger 14.

The hydrogel 48 may be made of different materials including, but notlimited to, polyethylene glycol, polyethylene oxide, polyacrylic acid,and polyvinyl alcohol. The hydrogel may contain additional salts (e.g.NaCl, KCl, NaBr, KBr, CaCl₂)) to further improve conductivity. Thehydrogel 48 (e.g. a liquid gel) can be pre-coated during the manufactureof the product or can be added by the user 78, clinician, or anyoneassociated with the system. The hydrogel 48 may extend beyond the firstelectrical conductor 18 or second electrical conductor 22. The hydrogel48 may also cover a larger surface area than the first electricalconductor 18 or second electrical conductor 22. The surface area of thefirst electrical conductor 18, or second electrical conductor 22, or thehydrogel 48 may include, but is not limited to, the range 10-500 mm²(e.g. 300 mm²). The hydrogel 48 may be covered with a liner 52 at thetime of manufacture to protect the hydrogel 48. The liner 52 is removedfrom the hydrogel 48 prior to application of the hydrogel 48 to thefinger 14 and can be reapplied to the hydrogel 48 after the hydrogel 48is removed from the finger 14.

The first electrode 16 and second electrode 18 can comprise a breathablematerial (e.g. silver-coated fabric electrodes). In some embodiments,the flexible strap 12 can comprise a breathable material. In someembodiments, an additional breathable material 50 positioned around theelectrodes against the skin and/or on the non-skin-contacting surface ofthe electrodes may be included. The breathable material can allowmoisture to evaporate. In some cases, the breathable material may bemoisture wicking (e.g. polyester) to improve moisture removal from theskin. In some embodiments, the electrodes may include a hole (i.e.annulus shape) or several holes to allow moisture to evaporate from theelectrodes. If moisture is not allowed to evaporate from the skin, itcan accumulate between the electrodes and skin surface 202. This mayresult in the shorting of the electrodes, such as causing a more highlyconductive EDA output that may be more representative of sweat poolingunder and around the electrodes than of the activation of the sweatglands. The evaporative removal of moisture can also improve comfort forthe wearer. The moisture vapor transmission rate of the breathablematerial includes, but is not limited to, a range of at least 300g/m²/24 hrs. (e.g. 1000 g/m²/24 hrs).

Now, with reference to FIG. 9, instead of including electrodes tomeasure EDA, some embodiments of the system 10 can include at least fourelectrodes to make a 4-electrode bioimpedance measurement. With a4-electrode measurement, current is supplied through two electrodes 94(current supply electrodes 94), and voltage is measured from twoseparate electrodes 96 (voltage sense electrodes 96). This negates theeffects of the electrode impedance and the impedance of a deeperunderlying volume of tissue is measured instead of the skin andelectrode surface impedance that dominate the two electrode measurement.

The four electrodes can enable measurement of the bioimpedance of theentire finger volume, which can indicate the overall amount of fluid inthe finger. This could be used as an indicator of the amount of fluid ina limb resulting from conditions such as lymphedema or heart failure.These four electrodes could be positioned on a single finger segment orextend across multiple finger segments. Finally, the device couldmeasure 4-electrode bioimpedance and EDA from the same four electrodesby switching between two circuits such that one or more 4-electrodebioimpedance measurements are taken from the electrodes with a4-electrode bioimpedance measurement circuit and then at least twoelectrodes are switched to connect to a circuit for measuring EDA andone or more EDA measurements are made before switching back.

Referring back to FIG. 1, a pulse sensor 32, which can measure a bloodvolume pulse waveform, may be positioned against the finger 14 betweenthe first electrode 16 and second electrode 20. The pulse sensor 32 canbe a photoplethysmography (PPG) sensor 38 with at least one opticalemitter (e.g. light emitting diode 30) and at least one photodetector 36(e.g. photodiode, phototransistor). The light emitting diode 30 andphoto detector 36 are likely oriented longitudinally on the palmarsurface 76 of the finger 14 to maximize the space for the firstelectrode 16 and second electrode 20 of the electrode sensor. The lightemitting diode 30 and photo detector 36 center-to-center spacing mayinclude but not be limited to a range of 3 mm to 15 mm (e.g. 6 mm). Thepulse sensor 32 could alternatively be another type of sensor than a PPGsensor (e.g. acoustic, 4-electrode bioimpedance).

Examples of the physiologic parameters which can be determined from thepulse signal, include heart rate (HR), heart rate variability (HRV),blood pressure (BP), pulse wave velocity (PWV), respiratory rate (RR),respiratory rate variability (RRV), tidal volume (VT), tidal volumevariability (TVvar), minute ventilation (MV), stroke volume (SV),cardiac output (CO), cardiac index (CI), oxygen saturation (SPO2), andCO₂ concentration. Multiple sensors may be needed to determine some ofthe physiologic parameters. For example, two pulse sensors, or an ECGand pulse sensor, may be needed for measuring PWV.

A thermistor 34 or thermal sensor measuring temperature (e.g.thermocouple, diode temperature sensor, transistor temperature sensor)and/or a heat flux sensor 40 (e.g. Peltier module) may be positionedagainst the finger 14 between the first electrode 16 and secondelectrode 20 of the electrode sensor. The thermistor 34, or thermalsensor, may be included, in addition to, or instead of, the PPG sensor.The thermal sensor measures the changes in skin temperature and/or heatflux associated with vasoconstriction and vasodilation.

The sensors can be held to the finger 14 with a flexible strap 12 thatwraps around the finger 14. The flexible strap 12 can be a linear strapthat is wrapped around the finger 14 in one direction or two directions.Alternatively, the flexible strap 12 can be a loop that is stretched tofit over the finger 14. The flexible strap 12 can be made of a varietyof material constructions including, but not limited to, knit, woven,non-woven, spun laced, foam, or thin polymer film. The flexible strap 12material could be made of a variety of different materials including,but not limited to, polyester, rayon, polyurethane, silicone,polyethylene, polyvinyl chloride, and polyolefin. The flexible strap 12can have an adhesive on the skin-facing side to stick to the finger orto itself. The flexible strap 12 material can also be designed to attachto itself without adhesive, or attached by a clip or other mechanism.

The flexible strap 12 may be stretchable with a low modulus ofelasticity. The modulus of elasticity of the strap includes, but is notlimited to, a range of 0.05-2 lb/inch of strap width or more narrowly0.05-1 lb/inch. A flexible strap 12 with low modulus of elasticity isrobust to variation in application tightness such that the pressurebetween the finger 14 and the PPG sensor varies only slightly withrelatively larger variations in band tightness. Low applicationrepeatability and reproducibility is expected by users 78; even so,other known systems do not incorporate a low modulus strap. Pulseoximetry monitors held to the finger 14 by relatively stiff tape havethe tendency to be applied either too loosely or too tightly such thatthere is either poor contact or displacement of capillary blood underthe sensor leading to poor signal quality. The flexible strap 12 may beintegral to the sensor housing 24 (shown in FIG. 1) or detachable fromthe sensor housing 24 so that it can be replaced. The first electrode 16and second electrode 20 (shown in FIG. 1) may be integrated into theflexible strap 12.

FIGS. 1-4 illustrate how the sensor housing 24 can be coupled to theflexible strap 12 through the use of snaps. Referring to FIG. 1, thesystem 10 can comprise a first female snap 54 that can be coupled to theflexible strap 12 and can be conductively coupled to the first electrode16. The system 10 can also comprise a second female snap 56. The secondfemale snap 56 can be coupled to the flexible strap 12 and can beconductively coupled to the second electrode 20. In several embodiments,the first female snap 54 can be coupled to the first electrode 16 via afirst conductive portion 58, shown in FIG. 1 and FIG. 2. The firstconductive portion 58 can extend from a first side portion 72 away fromthe first electrode 16 along at least the second direction Y that can beperpendicular to the first direction X. The first conductive portion 58can additionally extend away from the first electrode 16 along the firstdirection X. The second female snap 56 can be coupled to the secondelectrode 20 via a second conductive portion 60. The second conductiveportion 60 can extend from a second side portion 74 away from the secondelectrode 20 along at least the second direction Y that can beperpendicular to the first direction X. The second conductive portion 60can additionally extend away from the second electrode 20 along thefirst direction X. Furthermore, as shown in FIG. 7, the sensor housing24 can extend along a third direction Z that can be perpendicular to thefirst direction X and the second direction Y.

In some embodiments, the system 10 can further comprise a first malesnap 62 that can be coupled to the sensor housing 24. FIG. 3 illustratesthe first and second male snaps 62, 64 on the sensor housing 24. Thefirst male snap 62 can be arranged and configured to snapably couple tothe first female snap 54. A second male snap 64 can be coupled to thesensor housing 24. The second male snap 64 can be arranged andconfigured to snapably couple to the second female snap 56.

In several embodiments, the sensor housing 24 can then be coupled to theflexible strap 12. The first female snap 54 can fold toward a middleportion 73 of the flexible strap 12 and can snapably receive the firstmale snap 62. The second female snap 56 can fold toward the middleportion 73 of the flexible strap 12 and can snapably receive the secondmale snap 64. FIGS. 4 and 5 show how the second conductive portion 60can fold to allow the second female snap 56 and the second male snap 64to snapably couple and connect the sensor housing 24 to the flexiblestrap 12. FIG. 7 illustrates how to couple the sensor housing to theflexible strap 12 by folding the first conductive portion 58 with thefirst female snap 54 toward the sensor housing. The first female snap 54can then snapably couple to the first male snap 62.

The electrical circuit including a processor and power source may behoused in the sensor housing 24, housed in a separate electronicshousing of a data receiving module 88 (e.g. one that is mounted to thewrist) or distributed within multiple housings. As illustrated in FIG.6, in some embodiments, the system 10 can further comprise a cable 95that can communicatively couple the first electrode 16, the secondelectrode 20, and at least one sensor 26 with the data receiving module88. FIGS. 1, 2, and 4 demonstrate how the cable 95 can attach to thesensor housing 24.

The electronics housing of a data receiving module 88 may be connectedto the sensor housing 24 by a cable 95. The cable 95 can attach to theproximal side of a wrist-mounted electronics housing of the datareceiving module 88. The cable 95 can include an adjustable loop so thatthe system 10 can be used on a wide range of different hand 84 sizes.While FIG. 6 shows the data receiving module 88 around the wrist of theuser 78, in some embodiments, the data receiving module 88 can compriseat least one of a smartphone, tablet, and smart watch. In severalembodiments, the data receiving module 88 can comprise a networkinterface 92 that can be connected for wirelessly communicating data 11to another device 93.

Referring to FIG. 6, in several embodiments of the system 10, the datareceiving module 88 can comprise an accelerometer 90. An accelerometer90 may be included in the sensor housing 24, electronics housing of thedata receiving module 88, or both. The accelerometer 90 measuresaccelerations at or near the location of the finger 14 or wrist and canbe used in measuring motion and/or position. The accelerometer 90 signalcan be used to determine whether the user 78 is active. This activitydata can be useful as a clinical parameter (e.g. how much is the patientsleeping or walking in a day), as contextual information to interpretother data collected (e.g. the patient was sleeping or walking while themeasurements were taken), or as a way of disregarding measurements (e.g.the patient was too active and so the data should not be trusted duringthis time).

At least one button may be included on the surface of the sensor housing24 or electronics housing of the data receiving module 88. The button(s)may be used as marker buttons such that a timestamp is stored in memorywhen the marker button is pressed to indicate the time of an event.Alternatively, the button(s) may be used to initiate recording of a datastream.

The physiologic signal detecting device, or data receiving module 88,may output converted physiologic data 11. Data 11 may include one ormore of the following: analog or digitized signals (e.g. EDA signal,pulse waveform, temperature), calculated parameters (e.g. HR, HRV, EDL,EDR rate [EDRs/min]). The physiological data 11 may be filtered,smoothed, averaged, counted, subtracted, added, mathematically combined,or processed with any known signal processing methods. The physiologicaldata 11 or parameters may be further combined (e.g. HR and EDR rate orHRV, HR, and EDL) with an algorithm to create a useful output (e.g.index, status, prediction). The data may be used to provide a usefulindication (e.g. autonomic nervous system activity, stress, distress,panic, physiologic reactivity to traumatic stimuli, arousal,hyperarousal, engagement, excitement, fear, sympathetic tone,parasympathetic tone, probability of dropout from therapy, fluid status,probability of hospitalization, probability of treatment success,probability of recovery). The physiological data 11 may be used toassist patients, therapists, and medical providers to diagnose, assignsubtype, treat, monitor, reinforce progress, and motivate behavior.

Aclaris Medical, LLC has demonstrated that EDA can be reliably recordedwith the physiologic signal-detecting device having a first electrode 16and second electrode 20, positioned substantially on the lateralsurfaces 86 of a single finger 14 segment, wrapping from the sensors 26on the palmar finger surface 76 to the lateral surfaces 86 of the finger14. The EDL measured from the Aclaris Medical device on the singlefinger 14 segment strongly correlates to the EDL measured with a BIOPACSystems, Inc. data acquisition system from multiple fingers as istypically done. In another study, the EDL obtained from an Aclarisdevice with electrodes located on the ventral surface of the wrist wassignificantly lower and less strongly correlated with the BIOPAC EDLthan the EDL obtained from same-finger electrodes. Representative tracescan be seen in the figure below. The wrist electrodes commonly resultedin inconsistent responsiveness of the subjects to stressful stimuliwithin and across subjects.

Typical EDA waveforms during cognitive and emotional stressors are shownin FIG. 10. The top traces in each plot are measurements from the BIOPACelectrodes located on (a) the hyopthenar eminences and (b) the thumb andlittle finger. The bottom 2 traces in each plot depict the correspondingconductance levels from EDA electrodes (a: solid line—ipsilateral wrist;dashed line—contralateral wrist; b: solid line—ipsilateral index finger;dashed line—ispilateral middle finger).

Correlations between the Aclaris and BIOPAC EDL were evaluated over theentire recording session, which included both physical and autonomicnervous system response tasks. The correlations of the EDLs from thewrist electrodes were widely distributed between subjects, withcoefficients ranging from −0.8 to 0.8. Conversely, the correlationcoefficients from trials with the same-finger electrodes were tightlycentered on 0.94, ranging from 0.8 to 0.99.

The distributions of correlation coefficients for the linear regressionsof the BIOPAC and Aclaris EDL measurements taken from (a) theipsilateral (r_(ipsilateral), n=10) and contralateral wrists(r_(contralateral), n=9) and (b) the index (r_(index), n=30) and middlefingers (r_(middle), n=28) are shown in FIG. 11.

Mean and standard deviations of trial durations and within-trialcorrelations between the Aclaris and Biopac EDL measurements are shownin the table below. (Abbreviations: i—ipsilateral to Biopac;c—contralateral to Biopac)

r Sensor Duration (min) (Aclaris, Biopac) Location Trials, n M SD M SDWrist, i 10 85.3 4.3 0.06 0.46 Wrist, c 9 86.0 4.1 −0.03 0.43 Index 30119.7 7.8 0.92 0.05 Middle 28 102.6 37.2 0.93 0.04

In the same study, Aclaris also demonstrated that the positioning of theEDA electrodes to sides of the pulse sensor on the same finger segmentstill enables accurate heart rate measurement. In the table below, totaltrial heart rate deviation statistics and correlations between BiopacECG and Aclaris finger PPG are displayed as the mean and (standarderror) of the monitors' N trials. (Abbreviations: i—index; m—middle)

Mean Mean absolute deviation deviation Correlation Config Trials, N(bpm) (bpm) coefficient Finger, i 30 0.18 (0.36) 0.44 (0.39) 0.96 (0.11)Finger, m 30 0.05 (0.18) 0.35 (0.19) 0.99 (0.03)Interpretation

None of the steps described herein is essential or indispensable. Any ofthe steps can be adjusted or modified. Other or additional steps can beused. Any portion of any of the steps, processes, structures, and/ordevices disclosed or illustrated in one embodiment, flowchart, orexample in this specification can be combined or used with or instead ofany other portion of any of the steps, processes, structures, and/ordevices disclosed or illustrated in a different embodiment, flowchart,or example. The embodiments and examples provided herein are notintended to be discrete and separate from each other.

The section headings and subheadings provided herein are nonlimiting.The section headings and subheadings do not represent or limit the fullscope of the embodiments described in the sections to which the headingsand subheadings pertain. For example, a section titled “Topic 1” mayinclude embodiments that do not pertain to Topic 1 and embodimentsdescribed in other sections may apply to and be combined withembodiments described within the “Topic 1” section.

Some of the devices, systems, embodiments, and processes use computers.Each of the routines, processes, methods, and algorithms described inthe preceding sections may be embodied in, and fully or partiallyautomated by, code modules executed by one or more computers, computerprocessors, or machines configured to execute computer instructions. Thecode modules may be stored on any type of non-transitorycomputer-readable storage medium or tangible computer storage device,such as hard drives, solid state memory, flash memory, optical disc,and/or the like. The processes and algorithms may be implementedpartially or wholly in application-specific circuitry. The results ofthe disclosed processes and process steps may be stored, persistently orotherwise, in any type of non-transitory computer storage such as, e.g.,volatile or non-volatile storage.

The various features and processes described above may be usedindependently of one another, or may be combined in various ways. Allpossible combinations and subcombinations are intended to fall withinthe scope of this disclosure. In addition, certain method, event, state,or process blocks may be omitted in some implementations. The methods,steps, and processes described herein are also not limited to anyparticular sequence, and the blocks, steps, or states relating theretocan be performed in other sequences that are appropriate. For example,described tasks or events may be performed in an order other than theorder specifically disclosed. Multiple steps may be combined in a singleblock or state. The example tasks or events may be performed in serial,in parallel, or in some other manner. Tasks or events may be added to orremoved from the disclosed example embodiments. The example systems andcomponents described herein may be configured differently thandescribed. For example, elements may be added to, removed from, orrearranged compared to the disclosed example embodiments.

Conditional language used herein, such as, among others, “can,” “could,”“might,” “may,” “e.g.,” and the like, unless specifically statedotherwise, or otherwise understood within the context as used, isgenerally intended to convey that certain embodiments include, whileother embodiments do not include, certain features, elements and/orsteps. Thus, such conditional language is not generally intended toimply that features, elements and/or steps are in any way required forone or more embodiments or that one or more embodiments necessarilyinclude logic for deciding, with or without author input or prompting,whether these features, elements and/or steps are included or are to beperformed in any particular embodiment. The terms “comprising,”“including,” “having,” and the like are synonymous and are usedinclusively, in an open-ended fashion, and do not exclude additionalelements, features, acts, operations and so forth. Also, the term “or”is used in its inclusive sense (and not in its exclusive sense) so thatwhen used, for example, to connect a list of elements, the term “or”means one, some, or all of the elements in the list. Conjunctivelanguage such as the phrase “at least one of X, Y, and Z,” unlessspecifically stated otherwise, is otherwise understood with the contextas used in general to convey that an item, term, etc. may be either X,Y, or Z. Thus, such conjunctive language is not generally intended toimply that certain embodiments require at least one of X, at least oneof Y, and at least one of Z to each be present.

The term “and/or” means that “and” applies to some embodiments and “or”applies to some embodiments. Thus, A, B, and/or C can be replaced withA, B, and C written in one sentence and A, B, or C written in anothersentence. A, B, and/or C means that some embodiments can include A andB, some embodiments can include A and C, some embodiments can include Band C, some embodiments can only include A, some embodiments can includeonly B, some embodiments can include only C, and some embodimentsinclude A, B, and C. The term “and/or” is used to avoid unnecessaryredundancy.

While certain example embodiments have been described, these embodimentshave been presented by way of example only, and are not intended tolimit the scope of the inventions disclosed herein. Thus, nothing in theforegoing description is intended to imply that any particular feature,characteristic, step, module, or block is necessary or indispensable.Indeed, the novel methods and systems described herein may be embodiedin a variety of other forms; furthermore, various omissions,substitutions, and changes in the form of the methods and systemsdescribed herein may be made without departing from the spirit of theinventions disclosed herein.

What is claimed is:
 1. A system for sensing physiologic data,comprising: a flexible strap configured to surround at least a portionof a finger of a user; a first electrode located on the flexible strapand configured to contact the finger of the user; a second electrodelocated on the flexible strap and configured to contact the finger ofthe user, wherein at least one of the first electrode and the secondelectrode is configured to receive physiologic data from the finger ofthe user; at least one electrode snap assembly portion coupled to theflexible strap and conductively coupled to at least one of the firstelectrode and the second electrode; and a data receiving modulecommunicatively coupled to at least one of the first electrode and thesecond electrode and coupled to at least one data receiving module snapassembly portion, the data receiving module configured to receivephysiologic data from at least one of the first electrode and the secondelectrode, wherein the data receiving module is detachably coupled tothe flexible strap, wherein the at least one electrode snap assemblyportion comprises a first snap assembly portion and a second snapassembly portion, the first snap assembly portion coupled to theflexible strap that is elongate along a first direction and conductivelycoupled to the first electrode via a first conductive portion thatextends from a first side portion of the flexible strap away from thefirst electrode along at least a second direction that is perpendicularto the first direction, the second snap assembly portion coupled to theflexible strap and conductively coupled to the second electrode via asecond conductive portion that extends from a second side portion of theflexible strap away from the second electrode along at least the seconddirection, and wherein the at least one data receiving module snapassembly portion comprises a third snap assembly portion and a fourthsnap assembly portion, wherein the third snap assembly portion isarranged and configured to snapably couple to the first snap assemblyportion and wherein the fourth snap assembly portion is arranged andconfigured to snapably couple to the second snap assembly portion.
 2. Aflexible electrode strap, comprising: a flexible strap configured tosurround at least a portion of a finger of a user; a first electrodedirectly coupled to the flexible strap and configured to contact thefinger of the user, the first electrode conductively coupled to a firstsnap assembly portion; a second electrode directly coupled to theflexible strap and configured to contact the finger of the user, thesecond electrode conductively coupled to a second snap assembly portion;and at least one of the first electrode and the second electrodeconfigured to receive physiologic data from the finger of the user. 3.The flexible electrode strap of claim 2, wherein the flexible strap iselongate along a first direction.
 4. The flexible electrode strap ofclaim 3, the first snap assembly portion coupled to the flexible strapand conductively coupled to the first electrode via a first conductiveportion that extends from a first side portion of the flexible strapaway from the first electrode along at least a second direction that isperpendicular to the first direction, and the second snap assemblyportion coupled to the flexible strap and conductively coupled to thesecond electrode via a second conductive portion that extends from asecond side portion of the flexible strap away from the second electrodealong at least the second direction, wherein the first snap assemblyportion is arranged and configured to snapably couple to a third snapassembly portion coupled to a data receiving module, and wherein thesecond snap assembly portion is arranged and configured to snapablycouple to a fourth snap assembly portion coupled to the data receivingmodule.
 5. The flexible electrode strap of claim 2, wherein the secondelectrode is spaced from the first electrode along a first direction. 6.The flexible electrode strap of claim 2, wherein the first electrode andthe second electrode are positioned on an inner surface of the flexiblestrap.
 7. The flexible electrode strap of claim 2, further comprising anaperture extending through the flexible strap, the aperture configuredto receive at least one sensor configured to detect physiologic datafrom the finger, wherein the aperture is located between the firstelectrode and the second electrode.